Beneficial Effect of Salicylates: Insulin Action, Secretion or Clearance?

NCT02007577 | Completed Results

• 1 other identifier: 19254
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The possibility that obesity-associated inflammatory changes may play a role in the pathogenesis of type 2 diabetes (2DM) has led to increased interest in the possibility that salicylates might represent a useful treatment to improve glucose tolerance. Several studies, performed in patients with 2DM, as well as in nondiabetic, obese individuals, have demonstrated that salicylates have beneficial effects on glucose and insulin metabolism, but have not led to a coherent view as to the mechanism(s) involved. In this research proposal we will use specific methods to quantify insulin mediated glucose uptake (IMGU), glucose-stimulated insulin secretion rate (GS-ISR), and insulin clearance (I-Cl) in overweight/obese, nondiabetic, insulin resistant individuals. We will use the insulin suppression test (IST) to quantify IMGU in nondiabetic, overweight/obese volunteers to identify those individuals who are sufficiently insulin resistant to be enrolled in this study. We will then use the graded glucose infusion technique in these insulin resistant subjects to generate specific measures of both GS-IS and I-Cl. Following these baseline measurements, salsalate or placebo will be administered for one month to the participants, after which time the IST and the graded glucose infusion will be repeated to quantify and compare the changes in IMGU, GS-ISR, and I-Cl that have resulted from salsalate versus placebo. These results will provide for the first time quantitative data of the effect of salicylates on IMGU, GS-ISR, and I-Cl in overweight/obese, insulin resistant, nondiabetic individuals.

Conditions

Pre Diabetes; Insulin Resistant

Keywords

insulin resistant

Outcome Measures

Primary Outcomes (1)

• Quantification of Insulin Action With the Insulin Suppression Test (IST)

  Compare changes in insulin sensitivity as assesses by the IST before and after treatment between salsalate and placebo group

  after treatment for one month

Secondary Outcomes (1)

• Quantification of Insulin Clearance With the Graded Glucose Infusion Test (GGIT)

  one month on treatment

Study Arms (2)

salsalate 3500mg in 2 divided doses a day

ACTIVE COMPARATOR

Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner

Drug: salsalate

placebo

PLACEBO COMPARATOR

Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner

Drug: Placebo

Interventions

salsalate DRUG

Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner

salsalate 3500mg in 2 divided doses a day

Placebo DRUG

Participants will take 3 tablets with breakfast and 4 tablets with dinner

placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers,
• BMI 25-35kg/m2,
• Without severe anemia, kidney, liver disease or any current GI ulcers or bleeding
• Or on any medication contraindicated with salsalate

You may not qualify if:

• Recent history of GI bleed or ulcers,
• CVD or on anticoagulants
• Severe kidney or liver disease
• Allergies to aspirin
• Taking aspirin or anti inflammatory medication on a regular basis and cannot be taken off for the duration of the study

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Kim SH, Liu A, Ariel D, Abbasi F, Lamendola C, Grove K, Tomasso V, Ochoa H, Reaven G. Effect of salsalate on insulin action, secretion, and clearance in nondiabetic, insulin-resistant individuals: a randomized, placebo-controlled study. Diabetes Care. 2014 Jul;37(7):1944-50. doi: 10.2337/dc13-2977.

  PMID: 24963111 DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Interventions

salicylsalicylic acid

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. Gerald Reaven
• Organization: Stanford Universtiy

greaven@stanford.edu

650-724-3416

Study Officials

• Gerald M Reaven, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: December 11, 2013
• Study Start: July 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: May 5, 2016
• Results First Posted: May 5, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)